Thrombo-embolic protection and embolectomy/thrombectomy devices and methods

ABSTRACT

A device for intra-vascular embolic-thrombolic protection, as well as embolectomy/thrombectomy and atherectomy interventional procedures and methods. At least a portion of the working end of the device may be formed monolithically from a single hypodermic tube, or may be formed of monolithic inner and outer tubes with fixed or movable guide wire elements and imaging modalities. The device may comprise structures enabling coring, expansion within a vascular structure and vascular wall shaving, as well as filtration, stabilization and capturing of thrombotic or embolitic material during an intervention procedure.

BACKGROUND

Embodiments relate to medical devices and methods. More particularly,embodiments relate to thrombo-embolic protection andembolectomy/thrombectomy devices and methods. Additionally, embodimentsrelate to atherectomy devices and methods.

SUMMARY

Embodiments are drawn to medical devices and methods that may be usedfor, for example, intra-vascular thrombo-embolic protection andembolectomy/thrombectomy and atherectomy procedures. According to oneembodiment, an intra-vascular interventional device may be configured toprevent and/or remove clots, plaque or thrombus materials, in solid orsemi-solid form during a single insertion through the skin (percutaneousintra-vascular procedure), or directly into a vessel via open surgicalprocedures into any vascularized area of the body. Embodiments maycomprise structures and functionality for different phases of amulti-phase intra-vascular intervention procedure, which may beperformed by hand using any of a variety of imaging technologies, suchas Optical Coherence Tomography (OCT) or ultrasound or others, or byattachment to a stereotactic table stage or Magnetic Resonance Imaging(MRI) stage. Embodiments may also be inserted through the central lumenof another compatible intra-vascular interventional device. Embodimentsof an intra-vascular thrombo-embolic intervention device, along withassociated related subcomponents described herein, may be configured totrap and/or retrieve solid or semi-solid, contiguous and/or fragmentedmaterials and tissues as well as liquid and near liquid state tissuesand materials for analysis, diagnosis and further treatment. Embodimentsmay be configured to be portable, disposable or reusable and may be, forexample, electrically-, mechanically-, hydraulically-, pneumatically-and/or manually-powered and operated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, 1C, and 1D are perspective side views of components of athrombo-embolic interventional device, according to embodiments.

FIG. 2 show details of a work element of a thrombo-embolicinterventional device in a vascular structure, according to oneembodiment.

FIG. 3 is a side view of a work element of a thrombo-embolicinterventional device in a relaxed state, according to one embodiment.

FIG. 4 is a side view of a work element of a thrombo-embolicinterventional device in an unwound state, according to one embodiment.

FIG. 5 shows a work element of a thrombo-embolic interventional devicein an inverted step, according to one embodiment.

FIG. 6 shows perspective views of superposed pre- and post-inversionconfigurations of a work element of a thrombo-embolic interventionaldevice, according to one embodiment.

FIG. 7 shows a side perspective view of a work element of athrombo-embolic interventional device, according to one embodiment.

FIG. 8 shows a side view of a work element of a thrombo-embolicinterventional device, according to a method according to oneembodiment.

FIGS. 9A and 9B show two states of a work element of a thrombo-embolicinterventional device, according to one embodiment.

DETAILED DESCRIPTION

Reference will now be made in detail to the construction and operationof implementations of the embodiments illustrated in the accompanyingdrawings. The following description is only exemplary of the embodimentsdescribed and shown herein. The embodiments, therefore, are not limitedto these implementations, but may be realized by other implementations.

According to embodiments, a device for thrombo-embolic and mixedthrombotic lesion interventional procedures may be formed of one or moreco-axially located stainless steel (for example) hypodermic tubes (hypotubes) that are configured with (e.g., laser) cuts at its working end(the work element of the device, disposed at or near a distal end) toallow the work element to assume various forms, shapes andconfigurations at various stages of an interventional procedure,according to embodiments. The tube or tubes of the device may be rigidover portions of the device. According to other embodiments, the tube(s)may be flexible over the entire length or one or more portions thereof.Embodiments may comprise or be formed of materials other than stainlesssteel such as, for example, plastics or other suitable materials, whichmay incorporate the features of the work elements described herein.

FIGS. 1A, 1B, 1C, and 1D are perspective side views of components of adevice, according to embodiments. The device if FIGS. 1A-1D may beconfigured to thrombo-embolitic interventional procedures, according toone embodiment. As shown, FIG. 1A is a side view of a work element 13 ofa device 10 in a resting state, configured as an outer component 14 withnosecone 15, which also acts as a twisting brake. The outer componentmay be configured with straight and succeeding spiral cuts in a standardhypo tube. These laser cuts, according to one embodiment, may terminateat the proximal end of the work element (the distal portion of a device10), leaving a tube that may run proximally to a handle 12 (not shown inthis view).

A nosecone 15, as represented with angled lines that may represent sharpblade elements, may be rotated with the remainder of device 10 in lowprofile state according to an embodiment, in order to advance throughthrombo-embolic or mixed (plaque/thrombo-embolic type) lesions, toprovide a channel and to enable downstream embolic protection oncebeyond the obstruction.

FIG. 1B shows a flexible component 16 of a work element 13 of a device10, according to one embodiment. As shown, flexible component 16 may beformed of a stretchy, partially porous material that may become moreporous when it is stretched as a result of activation of the workelement 13. The flexible component 16 may be slipped over a nose cone 15of work element 13, and may serve as a particle trap for embolicmaterials that may be released by another intra-vascular interventionaldevice, with which device 10 may be used in conjunction, according toone method. Flexible component 16 may also serve as an elastic componentto cause the nosecone 15 of work element 13 to return to its originalconfiguration of a smaller diameter, or resting position, as shown abovein FIG. 1A. Flexible component 16 may be used to cover an embodiment ofa nosecone 15 comprising cutting elements that may be shielded untilneeded for boring through vascular obstructive material. Flexiblecomponent 16 may also be or comprise an inflatable balloon that may beeven lower profile than the embodiment shown herein. Such a balloon maybe advanced ahead of (distal to or downstream from) device 10 to providean even more distal protective component. The flexible component 16 maybe inverted/everted by the advancement of device 10 into the proximalend of flexible component 16 to enable smooth passage of device 10 andmay also, by the same action, trap any embolic material betweencomponent 16 and device 10, according to an embodiment. According to oneembodiment, device 10 may be configured to slide through the center offlexible component 16 which, when inflated, may assume the shape of anelongated-side-wall, hollow tube, with an inflated collar configuration,which may be further configured to have an open center that issufficiently large to enable device 10 to slide there-through, accordingto another embodiment. Component 16 may be configured as an elongatedballoon having a sufficiently low profile in its deflated, unexpandedstate to enable device 10 to slide over its outer circumference, onceany thrombo-embolic or mixed material (complex obstruction containingboth thrombo-embolic and plaque-type components) if in a complex lesion,is removed by device 10, to thereby render the vessel safe enough toallow deflation of component 16 according to an embodiment.

FIG. 1C shows a side view of an inner tube member 17 of a work element13. Inner tube member 17 may be configured to spread the straight andspiral portions of an outer tube 14 when it comes into contact andinterlocks with nosecone 15. According to one embodiment, such an innertube member 17 may be configured with castellations or otherconfigurations at its distal-most free end that, when pressed againstthe inside of nosecone 15 and twisted, may act upon it tocorrespondingly twist nosecone 15 of outer tube 14, In turn, suchtwisting of nosecone 15 may unwind the spiral cuts of outer tube 14,forcing them to resiliently expand in overall diameter inside a vascularstructure as they at least partially untwist. Also shown in this figureare openings “o” that are configured to allow liquids to pass, but thatare sized such that any solid materials or particles will tend to passby such openings to be trapped in the nosecone 15 of FIG. 1A. Inner tubemember 17 may be configured as a vacuum conduit, its castellationconfiguration serving to maintain a small gap through which particulateand gelled matter may be suctioned for removal, according to anembodiment.

FIG. 1D shows a side view of a movable guide wire or catheter 18 of workelement 13, according to one embodiment. According to embodiments, sucha guide wire component 18 may be sufficiently small, for example from0.009″ to 0.014″, to be passed through a very small inner lumen ofdevice 10 such that device 10 may be easily passed through a 4 French or5 French guiding catheter. Such a guide wire 18 may be shapeable and/orsteerable at its distal end and may also be configured with a bushingelement 19 that may bear against the distal rim of nosecone 15, such asthat of FIG. 1A above, in order to serve as a bearing surface to spreadthe straight and spiral cuts of an outer tube 14. Bushing element 19 maybe used to vary the slit-like opening between itself and the distalnosecone of device 10 or flexible component 16. When used in thismanner, when vacuum is applied in the center of device 10 in aconfiguration in which the inner tube element is used as a conduit forvacuum, bushing element 19 may be movable to vary the size of theslit-like openings to optimize vacuum and also to control the size ofparticulate matter being suctioned in such slit-like openings, accordingto an embodiment. According to one embodiment, guide wire 18 may also beconfigured to comprise opening blocker elements that may, when aligned,block the openings in inner tube 17 designated “o” in FIG. 1C and thatmay, when twisted out of alignment, open the openings “o” in inner tube17.

FIG. 2 shows details of a work element 13 comprising the componentsshown in FIGS. 1A, 1B, 1C, and 1D, according to one embodiment. The workelement 13 may be, according to one embodiment, a monolithic structurecomprising a plurality of twisted slats or ribbons formed from a singlestainless steel hypo-tube. The slats or ribbons may be formed from thesingle hypo tube by laser cuts such as the kerfs shown in the outer tube14. A second inner tube 17 may be provided to serve as an actuatingcomponent to expand (by at least partial untwisting, for example) theslats or ribbons formed by the laser kerfs. Work element 13 may thusalso comprise a vascular expanding device that does not require aballoon element, according to one embodiment. According to anotherembodiment, the work element 13 may be deployed to augment theoutwardly-directed pressures of an expanded balloon element against thewalls of a vascular conduit, to aid in the beneficial expansion thereof.Work element 13 may be further configured to comprise sharp struts that,under pressure from its own expansion or together with additionalballoon expansion forces, may be used to alter the restriction strengthof the obstructive material, to render it easier to expand by expansionforces. Such sharp struts may, in operation, at least superficially cutthe obstructive material, rendering it more susceptible to yield underpressure, in a similar manner that glass is more easily and controllablybroken once even a superficial scoring line has been made therein. Workelement 13 may be rotated, oscillated and/or translated to enable afully contacting (i.e., all around the inside diameter of a lesion)sabre-like, sawing or draw-knife-type cutting-scoring action to raisethe level of cutting efficiency applied to a lesion according to anembodiment. Work element 13 may thus serve as an atherectomy device,since once obstructive material has been sliced away from the vascularwall, the material will necessarily be located inside device 10 and maythereafter be subjected to collection with vacuum, simple trapping forlater removal or other forms of active tissue transport out of thevascular space, in the proximal direction within device 10, according toembodiments. Outer strut portions of work element 13, once expanded, maybe detached and left in situ to serve as a temporary removable orabsorbable stent, or it may serve as a permanently-implanted vascularscaffold (stent).

An expanded work element 13, in one embodiment, may be used as atemporary stent without being detached from its proximal portion,thereby allowing or maintaining blood flow as an intermediate, timegaining step between other vascular intervention procedures. Indeed,such use as a temporary stent may be advantageous to use before, duringor after other interventional procedures to allow other supportingvascular structures to be worked on during a complex interventionalprocedure. According to one embodiment, when the device is used as anatherectomy device, it may be advantageously advanced into a nearlyoccluded vascular structure. Several passes may be made through arestricted segment of the vascular structure, with each pass being madeusing a slightly greater outside diameter of the work element, which maybe adjustable. In so doing, a smooth opening through the vasculature maybe gradually and gently enlarged. Additionally, according to oneembodiment, if a graft is to be placed in the smooth bored inner surfaceof a vascular structure, the graft may be gently wrapped around a workelement that is in its most relaxed, or smallest diameter,configuration. The work element with wrapped graft may be advanced tothe graft site, expanded to place the graft concentrically against theinner smooth wall of the vascular structure. The so-placed graft may beheld in place until the distal and proximal edges of the graft are fixedin place. Advantageously, use of a work element as a graft placement,expansion and anchoring device allows blood flow through the expandedwork element spirals during placement of the graft. This also allows thegraft to be fixed in place by other interventional devices andmodalities, after which the work element may be withdrawn from the body.According to one embodiment, anchoring elements may be provided at theproximal and/or distal ends of the stent and/or graft placing workelement. These anchoring elements may comprise, for example, barbs,hooks and/or other shapes that may be twisted or pressed into placeusing one of the embodiments of the work element shown and describedherein.

As shown in this figure, the castellations of the inner tube 17, asshown in FIG. 1C above, may engage the kerfs of the outer tube 14 at thedistal end, and a torque moment applied on the inner tube 17 whileholding the outer tube 14 stationary (non- or differentially revolvingwith relation to inner tube 17) will thus deploy the slats of the outertube 14 and cause the effective diameter of the work element 13 toexpand. One of the advantages of the use of castellations on the innertube to positively engage the distal end of the outer tube for actuationis that, once an inner tube 17 has performed its function, it may bewithdrawn proximally to provide more internal space within the outertube 14 for clot or debris materials (resulting from an interventionalprocedure) to fill in thus-enlarged space to make the device easier toretrieve once that internal space is filled.

According to one embodiment, the inner tube 17 may not be castellated atits distal end, but may be laser welded, for example, at its distal endto the outer tube 14. FIG. 2 shows such a work element 13 in a vascularstructure with a side branch denoted “SB”. It should be noted that withsuch a placement, the kerfs that are widened as a result of the twistingmoment imparted to the outer tube 14 by the inner tube 17 may allowfluid passage, shown as “f” in this figure, from the main vessel to theside branch and downstream along the main branch, but may trap andprevent at least some embolic matter from flowing downstream, assumingthat blood flow is from right to left and as implied by the shape andangle of the side branch in this figure. Such embolic materials, shownas particles “p” in this figure, may continue to flow downstream withinthe main channel of the main blood vessel to be trapped in the nosecone15 with its flexible outer coating 16.

According to embodiments, various longitudinal sections of the outertube slats formed by laser kerfs may be of different hardness orflexibility as a result of, for example, heat treatment or shapeconfiguration, as examples of such treatments, to allow a variety ofshapes to be formed by the deployed slats of the outer tube 14. As such,such shapes may serve to impart different functionalities to the workelement, which may include serving as an atherectomy work element toshave plaque or other materials from a vascular structure's internalwalls and capture such materials in a deployed flexible element 16, thuspreventing their escape downstream. In such an embodiment, the laserkerfs may be formed as secant cuts, rather than radius cuts in the outertube to impart a sharp leading edge to each slat. In such an embodiment,it may be advantageous to correctly size the outer diameter of thedeployed slats of the outer tube of the work element, in order todetermine how aggressively plaque may be shaved from the inner walls ofa vascular structure.

According to further embodiments, an inner tube 17 or outer tube 14 maybe configured for aspiration from its or their central lumens to removeembolic material during an interventional procedure. Additionally, workelement 13 may be configured to contain or enable passage of any of anumber of compatible imaging modalities, such as a guide wire with fiberoptic camera, ultra sound imagery capturing or OCT scanning, forexample.

FIG. 3 is a side view of a work element of a thrombo-embolicinterventional device in a relaxed, resting or relaxed (e.g.,un-expanded) state, according to one embodiment. In this view, outertube 14 is in its most axially elongated and minimum diameterconfiguration. Elements such as the nosecone 15, fixed or removableguide wire 18 and a stiff or flexible body portion connected to the workelement 13 are also shown. In this configuration, device 10 may beintroduced into a vascular structure and induced to cross over an areaof thrombus, embolus or thrombotic occlusion. As indicated in thisfigure, different longitudinal areas or sections of the work element 13may be configured to be straight or spiral-cut, and may include shapesor hardness features that may influence the three-dimensional shape ofthe work element 13 in this deployed configuration, according toembodiments. Additionally, a flexible membrane element 16, such as shownin FIG. 1B, or a perforated outer coating element may be incorporatedinto the work element 13.

FIG. 4 is a side view of a work element of a thrombo-embolicinterventional device in an unwound state, according to one embodiment.As shown, the device 10 of FIG. 3 is shown in a configuration in whichthe work element 13, including the outer tube 14 and other elementspreviously described above, are in a maximum unconstrainedconfiguration, i.e., unconstrained by a vascular wall in which it may beplaced. If placed in a vascular structure, the maximum diameter of thework element 13 may be comparatively less than the maximum unconstraineddiameter and may be carefully tuned to allow the laterally-expandedslats of the outer tube to shave plaque or other material from the wallsof such a vascular structure, while enabling blood flow and thecapturing of debris to occur, according to embodiments.

FIG. 5 shows a work element of a thrombo-embolic interventional devicein an inverted configuration, having passed through a thrombus in avascular structure, according to one embodiment. In this embodiment,once deployed distally to a thrombus, the work element is first expandedin the manners described above. Thereafter, an inner tubular element maybe advanced forward (i.e., in the distal direction), expanding thestruts thereof until they buckle and cause inversion of the proximalportion of spiral strut elements which, according to one embodiment, maybe separable from the outer tube. The entire device may be retractedproximally during this maneuver. This proximal retraction creates asurrounding, capturing motion as the more distal strut elements enablethe outer rim, where flexible struts that are progressively inverted, tomeet up with stiff, membrane covered, more firmly radially outwardlydisposed portions of themselves. The distal portions of the strutelements may be “stiffer” and more prone to remain extended that theproximal portions of the strut elements. The distal portion of the strutelements may additionally be covered with an ultrathin membrane. Thiscauses inversion all the way to the point where they end in thenon-kerfed proximal portion of the main outer tube. At this point they,being shorter in length than the more stiff distal portions ofthemselves, while continuing to be forced distally by the proximal disc(of smaller diameter than the main tube) or alternatively by the maintube, non-kerfed section, act as bowstringing tethers to help bring theproximal-most sections of the stiffer portions of the strut inwards attheir most proximal point (where stiff meets less stiff sections). Thismotion may be accompanied and augmented by a re-twisting of the strutelements to further squeeze down on and more firmly capture thromboticand mixed debris. In this manner, any debris thus internalized by thesemechanisms and elements may be firmly, actively and securely captured.The device 10 may be introduced into a vascular structure from either anupstream or downstream position relative to the thrombus to be passed.

FIG. 6 shows a perspective view of superposed pre- and post-inversionconfigurations of a work element 13 of a thrombo-embolic interventionaldevice, according to one embodiment. It is to be understood that thedevice 10 does not assume the pre- and post-inversion configurationsshown in FIG. 6 at the same time, as both configurations are shown forpurposes of explanation only. In this figure, the laterally expanded,but not yet forwardly deployed slats of an outer tube are shownsuperposed over the configuration discussed relative to FIG. 5 above. Inthis latter configuration, the inner tube may be configured with acollar mechanism to capture the proximal portion of the outer tubeslats, and thus drive them forward after having imparted a twistingrotational force to the outer tube slats to deploy them laterally. Sucha combined twisting force to deploy laterally, and then distal axialforce alone or in combination with further twisting to reach a secondconfiguration, such as in FIG. 5 above, allow for an efficient andpositive closure and constitute an effective entrapment mechanism toprevent embolic material from flushing downstream from an interventionalsite, according to one embodiment. As discussed above, some or all ofthe struts of the work element may be sharpened along an edge thereofsuch that, in the fully expanded state, work element 13 may beconfigured, deployed and used as an expandable, circular atherectomydevice to clear adherent obstructive materials from vascular walls. Sucha device may simultaneously collect such cut obstructive materialswithin the confines of work element 13 of device, 10 according to anembodiment.

Similarly, once configured as in FIG. 5, work element 13 may have onlyportions of its sharpened strut elements near the extreme flex-pointsthat form the circumferential rim, which rim is firmly pressed againstthe lesions lining the vascular walls. In this embodiment, rotation,oscillations and proximal translation or a combination of strut elementand the rim formed by the extreme flex points thereof may serve to severthe obstructing lesions from vascular walls. The circumferential rim ofsharpened and flexed struts or slats may, in this manner, form thecutting edge that cuts and severs the obstructing lesions. According toone embodiment the cut and severed obstructing material may then becollected in, for example, the manner previously described. According toembodiments and as shown in FIG. 6, work element 13 may be configured tobe attached to a main outer tube 14 of device 10 at either of its ends.In this manner, work element may be used in a vessel and advanced withinthe vasculature in an orientation in which the flow is antegrade (i.e.,approaching an arterial conduit or vein graft from upstream side) orretrograde i.e., approaching either of those structures from downstreamside and vice versa in direction for in-situ venous conduits).

According to embodiments, the work elements 13 may be constructed of orcomprise shape memory materials and configured such that, exposure tobody temperatures causes the work element to expand under the forcescontained within the materials, augmented or combined with geometricalcuts configured to optimize and refine such forces. According to oneembodiment, other portions of work element 13 may also aid expansion ofthe work element 13. In another embodiment, such expansion may beconfigured to allow or cause detachment of all or certain portions ofwork element 13 such that these elements may be left in-situ to serve astemporary or permanent vascular scaffolding (stent). As temporaryscaffolding, these elements may be configured to be retrievable byreversing the process (i.e., subjecting the materials of work element 13left in-situ to higher or lower temperatures or another form of energy)and re-attaching work element 13 or portions thereof, in situ, to aretrieval device 10, according to embodiments.

FIG. 7 shows a side perspective view of a work element of athrombo-embolic interventional device, according to one embodiment. Inthis view, the slats of the outer tube have been deployed forward areabout halfway towards full expansion of the work element 13 within avascular structure. This illustrates that the ultimate outer diameter ofthe work element may be adapted to the morphology or diameter of thevascular structure within which it may be introduced and deployed.

FIG. 8 shows a side view of a work element of a thrombo-embolicinterventional device, according to one embodiment. This view shows alater in time configuration of the device in operation, as compared withthe views shown in FIGS. 5, 6 and 7. Indeed, in FIG. 8, the work elementis shown in a completely deployed or closed configuration with a maximumoutside diameter, and with a double basket effect as a result of theinversion of a portion of the outer tube slats within a more distalportion. Such a configuration may allow for complete diametrical sealingof the inner lumen of a blood vessel, while still allowing blood flowand simultaneous capture of very small particulates such as embolicmaterials. Such a work element in this deployed shape may also bewithdrawn from a blood vessel without risk to sensitive vascular wallstructures, while retaining captured materials in its double basketshape.

FIGS. 9A and 9B show two states or configurations of a work element 13of a thrombo-embolic interventional device 10, according to oneembodiment. FIG. 9A shows the work element in its initial state, ascompared to the post-interventional state of the device shown in FIG.9B. In FIG. 9A, rotational torque force has not been applied to theouter tube slats, which remain tightly closed for ease of penetration ofa thrombus, for example. In this state, the work element has a lowprofile suitable for insertion in small diameter openings andstructures. FIG. 9B shows the device of FIG. 9A in a post interventionalstate, in which a thrombus has been captured within the now-closed outertube. As shown, the closed outer tube may be configured to wrap, envelopand encapsulate the cut thrombus material within in its central lumen.In this configuration, the work element of the device 10 is ready to bewithdrawn from the body, together with the cut and captured material.

According to one embodiment, the device 10 may be implemented in ahand-held configuration comprising an ergonomically comfortable andsecure handle at its proximal end. Work element 13 may extend from thehandle to enable the device 10 to be easily grasped, directed andoperated with one hand. Other embodiments may be readily adapted to fitonto any number of guiding devices such as a stereotactic imaging stageor other guidance modality such as MRI. As shown, one embodiment of thedevice 10 may comprise one or more sharp elements (herein, alternativelyand collectively referred to as “work element 13”) projecting forwarddistally from the handle for the purpose of forward penetration, coring,shaving and capturing of cored or shaved materials in an interventionalprocedure. As shown, one embodiment may comprise a work element 13 thatmay comprise one or more sharp cutting tip or side blades to penetrateto the target site of the intended intervention. The entire device 10may be configured to be disposable or may be configured to be reusablein whole or in part.

A device 10, as disclosed herein, is an effective, low profileinstrument that does not require a constraining delivery device and thatalso incorporate a self-sealing retrieval system that does notnecessarily require a separate capture tube. Such a device, according toembodiments, may be configured for at least three main purposes,namely 1) distal protection filtering, with built in distal guide-wire,imaging and medication delivery conduit(s), (embolic protection device),2) embolectomy/thrombectomy retrieval, and 3) temporary vessel patencymaintenance. Additionally, one embodiment may be configured as adistal-to-proximal “crawling capture” device, which is also active inexpansion, crawling function and capture “sealing” function. Accordingto embodiments, devices 10 may make use of mechanical, active expansioncoupled with passive/active closure, relying on untwisting of spirallydisposed, living hinge incorporating elements, alone or in combinationwith compression/extension elements to enhance expansion, contractionand trapping/sealing of debris, whether capture in-situ(thrombectomy/embolectomy) is the therapy or prevention of distalembolization or clot propagation is the goal of the interventional useof a device 10. Such devices may comprise membranous elements, such asshown above in FIG. 1B, whose pore sizes can be controlled based onexpansion/relaxation of the stretching of strut elements. The devices 10may also enable central, filtered and unfiltered butparticulate-diverted, flows through and beyond the devices to nourishdistal vasculature watershed areas downstream.

According to embodiments, the device 10 may comprise a main tubularelement into which are formed a pattern of, for example, laser kerfsthat begin as straight cuts (generally parallel with the long axis ofthe tube) distally, to aid radial expansion when the cuts portion of thetube is compressed distal/proximal in the axial plane. These cuts maythen be more spirally disposed proximally to maximize their radialexpansion during “unwinding” of the helix by a combination of resistanceto twisting (the main tube) forces imposed by an inner tubular element.Both inner tubular element and outer main tube may proceed proximallyall the way to a handle element 12 that enables controlling the twistand compression functions at the distal working end of the device. Theaxial compression (result of which augments radial expansion of thetwisting “unwinding” forces) may be actuated by a combination ofresistance to forward travel of the distal nosecone of the device by theguide-wire element (in a variant where the inner tubular element isremovable), or the inner tubular element (in the case of the innertubular element being non-removable from the outer main tube, andessentially fixed to the nose cone), while the main tube is forcedforward by the inner tube element. This simultaneously opens the flowchannels in the inner tubular element. Alternatively, the proximal tubemay be both twisted and forced forwards by the portion of the main tubethat is proximal to the spiral kerf section, in which only one of theinner tubular element or the guide-wire element is needed in that case,assuming the guide-wire element is strong enough to prevent twisting ofthe nose cone), according to various embodiments. As thrombotic or mixedmaterial debris begins to fill the distal nose cone area, prevented asit is from traveling distally by the membranous portion covering thedistal roughly half of the kerf section of the main tube, the debris(cut material) accumulation creates a relatively lower pressure areadistal to the flow slots that help prevent debris from entering thesechannels. Additionally, the streamlined nature of the slots works toexclude all but the smallest and lowest inertia debris, while a shieldor flow chamber may also be incorporated for certain clinicalindications. The channel openings may be specifically configured topermit only high speed jets of flow, which generally dissolves anypartially clotted fluids. In certain clinical indications or milieussuch as acute myocardial infarction, pulmonary embolization and otheracute situations, structures may be provided to prevent the inclusion ofparticulate material. Such structures may exclude particulates throughpredetermined fenestration geometry alone or in combination with activetwisting of the inner tubular element. Fluids to dissolve the clot thatpass by centrifugal forces (occasioned by rotating at least the workelement) through the fenestrations are stirred to dissolve clot whileexcluding particulates. Assuming the rotational speeds may be optimizedfor imaging modalities, such imaging modalities may be included, forpurposes of up close imaging of thrombotic elements as well as theirexcision and transport during use of these devices. According to furtherembodiments, a motorized spinning guidewire may be provided and used inconjunction with the present devices 10 to a-traumatically stirdownstream to keep flows active and the clotting elements dissolved.According to a further embodiment, the entire outer main tube may begently spun. The spiral slats of the spinning outer main tube, in itsexpanded configuration, may be caused to a-traumatically sweep the wallsof an affected blood vessel. Dislodged or cut material may then becollected by the geometry of the most radially pressing elements locatedfurther upstream. If needed, vacuum may be provided, utilizing the innertubular element conduit, which can be switched back to distal flowprovision (with the source of vacuum unhooked or otherwise deactivated)once the bulk of the thrombotic or mixed debris is removed.

According to methods, during interventional procedures for cases such asthose of carotid angioplasty, stenting and endarterectomies, protectionagainst distal (into the brain vasculature) embolization is vital. Inthese cases, the primary material is friable, particulate plaque thatusually includes some thrombotic debris, although usually, it is fairlycommonly organized thrombus, rather than active. If the patient hasrecently had a transient ischemic attack (TIA) or reversible ischemicneurologic deficit (RIND which is usually longer and deeper than a TIA)the thrombus has already given rise to emboli, in any case, suchmaterial, once released, is capable of causing additional thromboticevents in the area local to which it embolizes. These same principlesapply to peripheral vascular interventions in other areas of the body,such as upper and lower extremities and renal arteries, among others. Inacute ischemic events, for example, acute myocardial infarction,pulmonary infarctions and peripheral arterial acute occlusions, thereare active thrombotic events and these include distal embolizationevents. In such cases, there are two vital needs, the first being toretrieve any active thrombus and the second being to administerpharmacological agents to prevent further thrombosis and clotpropagation while also minimizing the chance of (further) embolization.At the same time, any thrombi or emboli already too far distally locatedfor practical retrieval can be dissolved by so called “clot-buster”pharmacologic regimens. The key is to retrieve and remove thrombi andemboli from the major vessels since they serve the largest watershedareas and thus create the greatest and most permanent tissue damage.Additionally, the more thrombotic material removed, the less theclotting system is activated by free-floating elements. The lower theclot burden, the lower is the required dosage of “clot busting”medications. Another strong indication for thrombus removal and embolusprotection is in the attempted salvaging of old vein graft bypassconduits, which, when they become ectatic, are notoriously filled withthrombus in various states of organization. These are large bulkythrombi that are likewise notoriously prone to embolization oncedisturbed by interventional procedures. Regardless of the intervention,these require thrombus removal and protection against distalembolization. There are many other examples of indications such asdialysis grafts among others, but the examples cited herein most closelyrepresent the variety of types of vascular indications for removal(thrombectomy/embolectomy) and protection (embolic protection devices)against ischemia from vascular occlusion due to thrombi and embolibefore, during and after an interventional procedure.

According to embodiments, a device 10 may be introduced intra-vascularlyover a guide wire 18, which may be fixed or of a monorail “Rx” (rapidexchange) structure. According to one embodiment, the device 10, in itsresting form, may present an extremely low profile, making the device 10readily introducible into a distal vessel. Such a distal vessel may besmall and/or lined with fragile thrombus or plaque. The device 10 may beintroduced into a distal vessel for protection against embolic events,or it may be placed into an area of active clotting to prevent furtherclotting and to retrieve the majority of the clot, while allowingin-thrombus and distal injection of clot buster pharmacologic materials.According to one embodiment, device 10 may be configured to activelyand/or passively return to its resting low profile. In otherembodiments, the device 10 may also be configured to collect thromboticmaterial and not return all the way to its resting low profile. In stillother embodiments, clot material and other particulates may be vacuumedout such that a resting or near resting (smallest initial outsidediameter) may be achieved after the thrombotic material has been cut.Device 10 may be positively controlled to expand and contract, and mayalso be configured to compress in length or lengthen in order to deployand to capture thrombus/embolic matter definitively and safely duringremoval. Work element 13 of device 10 may be formed of or comprise shapememory materials or alloys that assume certain configurations when asource of heat is applied thereto. The work element, according tofurther embodiments, may comprise bimetallic materials configured todeform and to return to an initial, resting state. According toembodiments, the device 10 may cover more than a single line of radiallydisposed contact points in a vascular structure, and may functioneffectively in tortuous or irregularly-walled vessels as well as insmooth straight blood vessels. Device 10 may also allow flow to sidebranch blood vessels, which are ideally also protected while blood flowsare established and maintained in a main branch vessel, in spite of thelesser need for unconstrained blood flow that may be encounteredvis-à-vis a main vessel. According to one embodiment, device 10 maycomprise a flexible outer tube coating configured to function as anetting mechanism when such an outer tube is deployed in expanded form,or have very small perforations to allow a limited but acceptable amountof blood to flow to branch vessels.

According to one embodiment, a device 10 may be configured to be easilyretrievable in its collapsed state, whether in its initial, restingfully low-profile configuration or a nearly low profile state. Thisensures safe removal of the device, even in situations where the clotburden may be extremely high and in cases in which it is desired tocompletely remove the device 10 from the body in order to empty it ofits contents, such as may occur when aspiration is not present orutilized. The device 10 may incorporate features to provide a wide openflow accommodation pathway for the main artery, which pathway may becentrally located in the central lumen of device 10 and may also beaugmented by flow through other spaces. Such a central lumen flowpathway may be configured to prevent clot elements or other particulatesfrom being admitted therein. This may be accomplished by managing flowdynamics, as illustrated in the figures above, shielding, or anycombination of the management of flow dynamic and shielding, accordingto embodiments. The device 10 may be provided, according to embodiments,with deflectors for flow management, which may rely on a natural ventureshape to capture debris as it fills up the distal capture area. Suchembodiments are considered as being included in this description.

According to one embodiment, a guide wire may be left in place whendevice 10 is removed or exchanged. According to one embodiment, a fixedguide wire incorporated into device 10 may be removed with the device orleft in place. According to embodiments, device 10 may be configured toenable injection of blood thinners, such as heparin, or clot busters,such as urokinase and others, and may further accommodate the use ofplatelet inhibitors, vasodilators, cooling fluids and oxygen carriermaterials or medications. Device 10 may be configured to be compatiblefor use with other interventional devices and may be manufactured withextremely small diameters, such as 0.038″, or other desired dimension.

It is to be understood that the above descriptions are but exemplaryembodiments, principles and methodologies and that one or more of theinterventional steps or considerations described above may be omitted,while others may be added thereto, depending on the target site withinthe body or other operator methodologies. The order of some of the stepsmay be changed, according to the vascular interventional procedure.

The described embodiments may be formed of or comprise one or morebiocompatible materials such as, for example, stainless steel or otherbiocompatible alloys, shape memory alloys including for examplebimetallics and may be made of, comprise or be coated with polymersand/or biopolymer materials as needed to optimize function(s). Forexample, the cutting elements (such as the constituent elements of awork element 13 or nosecone 15) may comprise or be made of hardenedalloys, or carbon fiber or PEEK or other polymers or plastics, and maybe additionally coated with a slippery material or materials to therebyoptimize passage through living tissues of a variety of consistenciesand frictions. Some of the components may be purposely surface-treateddifferentially with respect to adjacent components. The various internalor external components may be made of any suitable, commerciallyavailable materials such as nylons, polymers such as moldable plastics,and others. The handle may be configured to render it adaptable to oneof any number of existing guiding platforms, such as stereotactic tablestages. The materials used in the present device may also be carefullyselected from a ferro-magnetic standpoint, such that the presentmaterial delivery or removal device maintains compatibility withmagnetic resonance imaging (MRI) equipment that is commonly used formaterial delivery or removal procedures. Vacuum/delivery assemblycomponents may comprise commercially available vacuum pumps, syringesand tubing for connecting to the present device, along with readilyavailable reed valves for switching between suction and emptying ofmaterials such as fluids, which may be suctioned by vacuum components.The fluids collected by the embodiments of the present device in thismanner may then be ejected into an additional external, yet portable,liquid storage vessel connected to the tubing of the present device, forsafe keeping and laboratory cellular analysis.

While certain embodiments of the disclosure have been described, theseembodiments have been presented by way of example only, and are notintended to limit the scope of the disclosure. Indeed, the novelmethods, devices and systems described herein may be embodied in avariety of other forms. Furthermore, various omissions, substitutionsand changes in the form of the methods and systems described herein maybe made without departing from the spirit of the disclosure. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thedisclosure. For example, those skilled in the art will appreciate thatin various embodiments, the actual physical and logical structures maydiffer from those shown in the figures. Depending on the embodiment,certain steps described in the example above may be removed, and othersmay be added. Also, the features and attributes of the specificembodiments disclosed above may be combined in different ways to formadditional embodiments, all of which fall within the scope of thepresent disclosure. Although the present disclosure provides certainpreferred embodiments and applications, other embodiments that areapparent to those of ordinary skill in the art, including embodiments,which do not provide all of the features and advantages set forthherein, are also within the scope of this disclosure. Accordingly, thescope of the present disclosure is intended to be defined only byreference to the appended claims.

What is claimed is:
 1. A device, comprising: a handle; a first tubecoupled to the handle, a distal portion of the first tube defining awork element comprising: a proximal end; a distal end; and a pluralityof slats formed by cutting the first tube between the proximal end andthe distal end of the work element such that each of the plurality ofslats spans a non-zero radial angle from the proximal end of the workelement to the distal end of the work element.
 2. The device of claim 1,further comprising a nosecone coupled to the distal end of the workelement.
 3. The device of claim 3, wherein the nose cone comprises aplurality of cutting elements.
 4. The device of claim 2, wherein adistal end of each of the plurality of slats is coupled to the nosecone.5. The device of claim 4, wherein differential rotation of the noseconerelative to the first tube or differential rotation of the first tuberelative to the nose cone causes radial movement of the plurality ofslats.
 6. The device of claim 1, wherein the plurality of slats in atleast a portion of the work element form a spiral pattern.
 7. The deviceof claim 1, wherein the plurality of slats in at least a portion of thework element are substantially parallel to a long axis of the firsttube.
 8. The device of claim 1, wherein the plurality of slats areconfigured to selectively bow radially outward and radially inwardbetween the proximal end of the work element and the distal end of thework element.
 9. The device of claim 1, wherein the plurality of slatsare configured to selectively bow radially outward and bow radiallyinward in response to differential rotation of the nose cone and thefirst tube.
 10. The device of claim 1, wherein the plurality of slatsare configured to selectively bow radially outward and bow radiallyinward in response to respective torsional forces applied to the firsttube.
 11. The device of claim 2, further comprising a second tuberotatably coupled to the handle and disposed co-axially with the firsttube, coupled to the nosecone.
 12. The device of claim 11, configuredsuch that differential rotation of the first and second tubes causes theplurality of slats to move in a radial direction.
 13. The device ofclaim 1, wherein at least a proximal portion of each of the plurality ofslats is configured to be drawn toward the distal end of the workelement until a proximal portion of each of the plurality of slatsdefines an angle of less than 90 degrees with a corresponding distalportion thereof.
 14. The device of claim 1, wherein at least a proximalportion of each of the plurality of slats is configured to be drawntoward the distal end of the work element until circumferential rim isformed.
 15. The device of claim 1, wherein each of the plurality ofslats forms a living hinge that is formed from the first tube.
 16. Thedevice of claim 1, wherein each of the plurality of slats is formed bylaser cutting the distal portion of the first tube along a predeterminedpath.
 17. The device of claim 16, wherein at least a portion of thepredetermined path forms a non-zero angle relative to a long axis of thefirst tube.
 18. The device of claim 1, wherein at least one of theplurality of slats comprises a cutting edge.
 19. The device of claim 1,configured as an embolectomy device.
 20. The device of claim 1,configured as a thrombo-embolic protective device.
 21. The device ofclaim 1, configured as an atherectomy device.
 22. The device of claim 1,configured for insertion in a patient vasculature and configured, inoperation, to enable blood flow at least from a point distal to the workelement to a point proximal thereto.
 23. A method, comprising: providinga device comprising a rotatable first tube, a distal end portion ofwhich defines a plurality of flexible slats that span a non-zero radialangle over at least a portion of their extent; inserting the distal endportion of the device into a vasculature of a patient; while rotatingthe first tube: radially expanding the plurality of slats; and cuttingtissue from walls of the vasculature; retracting the plurality of slatstoward a long axis of the first tube; and removing the distal endportion of the device from the vasculature of the patient.
 24. Themethod of claim 23, wherein at least a proximal portion of each of theplurality of slats is configured to be drawn distally until a proximalportion of each of the plurality of slats defines an angle of less than90 degrees with a corresponding distal portion thereof.